NCT05639036

Image Guided EVD Placement

Image-guided External Ventricular Drain Placement Trial: a Prospective Randomized-controlled Trial Pilot

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Hamilton Health Sciences Corporation · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

To determine if use of the Stryker Nav3 image guidance system offers superior results in external ventricular drain (EVD) placement compared to the standard free-hand technique.

Detailed description

An external ventricular drain (EVD) is a small tube that is placed into a space in the brain called a ventricle. This is done to drain fluid in the brain that sometimes builds up as a result of surgery or a traumatic brain injury/accident. This is one of most commonly performed procedures in Neurosurgery and is done bedside, not in the operating room. Typically, surgeons will use the "free-hand" technique to place these drains which involves relying on a CT scan, which shows the structures inside of the brain, and their knowledge of the anatomy of the brain and where the EVD should be placed. Image-guidance systems exist which create real time imaging of the patients brain and can act like a GPS to help guide the placement of the EVD in the correct spot. This trial is planned to determine if using the image guidance system does offer improved accuracy in EVD placement, lowering the number of attempts required and therefore the amount of time spent placing the EVD and risk of complications and infections. A pilot study will be done first, using a convenience sample at the Hamilton General Hospital to determine the feasibility of running a larger scale trial in the future.

Conditions

• External Ventricular Drain (EVD)
• Image Guidance

Interventions

Type	Name	Description
DEVICE	Image Guided External Ventricular Drain Placement Using the NAV3 System	Nav3 image guidance system used to assist with external ventricular drain placement
PROCEDURE	Free Hand External Ventricular Drain Placement	External ventricular drain will be placed with the standard free-hand technique

Timeline

• Start date: 2026-06-01
• Primary completion: 2027-06-01
• Completion: 2027-08-01
• First posted: 2022-12-06
• Last updated: 2025-04-01

Locations

1 site across 1 country: Canada